ContractPresolicitation

NOI to Sole Source to VaLogic, LLC

DEPARTMENT OF HEALTH AND HUMAN SERVICES• NOI-OD-26-000344
Response Deadline
May 13, 2026
5 days left
Days Remaining
5
Until deadline
Set-Aside
No Set aside used
Notice Type
Presolicitation

Contract Opportunity Analysis

The National Institutes of Health Clinical Center Pharmacy Department is seeking a sole-source contract with VaLogic, LLC for IQ/OQ/PQ qualification services for cold temperature units used to store pharmaceutical, sterile, and investigational materials. The work covers installation, operational, and performance qualification for new CTUs and follow-up qualification after critical repairs, with NIST-traceable 3-point calibration and both electronic and paper documentation. The requirement is tied to VaLogic’s existing Office of Research Services and Compliance contract and its technicians’ manufacturer-specific training and certifications for multiple CTU brands, along with 24/7 technical support and 72-hour service initiation at NIH in Bethesda, Maryland. The period of performance runs from November 5, 2025, through December 31, 2025, and the acquisition is described as below the simplified acquisition threshold.

Classification Codes

NAICS Code
541380
Testing Laboratories and Services
PSC Code
J066
MAINT/REPAIR/REBUILD OF EQUIPMENT- INSTRUMENTS AND LABORATORY EQUIPMENT

Solicitation Documents

2 Files
Sole Source Memo VaLogic.docx
Word•48 KB•May 8, 2026
AI Summary
The National Institutes of Health, Clinical Center, Pharmacy Department, is seeking a sole source justification and approval for specialty services from VaLogic Bio, Inc. for the qualification of cold temperature units. The acquisition, valued below the simplified acquisition threshold, is justified under FAR 13.106-1(b)(1) due to VaLogic Bio's unique qualifications, existing contract with the Office of Research Services and Compliance, and specialized training and certifications for various manufacturer's cold temperature units. Efforts to solicit other sources were limited due to these specific technical requirements and the contractor's established expertise and database access. The anticipated cost is deemed fair and reasonable based on price analysis. The agency will continue to seek competition through oral solicitations for future acquisitions.
Statement of Work for VaLogic IQOQ Testing (3).docx
Word•21 KB•May 8, 2026
AI Summary
The NIH Clinical Center's Pharmacy Department requires VaLogic, LLC for Installation, Operational, and Performance Qualification (IQ/OQ/PQ) services for its Cold Temperature Units (CTUs). These CTUs are vital for storing pharmaceutical drugs, sterile and non-sterile products, and investigational drugs used in NIH clinical studies. The services include initial and follow-up qualifications for new CTUs and follow-up qualifications for existing CTUs after critical repairs. The period of performance is from November 5, 2025, to December 31, 2025, and includes comprehensive IQ/OQ/PQ service, NIST-traceable 3-point calibration, documented evidence, electronic and paper documentation, and testing equipment calibration certification. The contract also mandates a 72-hour service initiation, 24/7 technical support via internet, and engineers with system-certified annual training.

Related Contract Opportunities

Project Timeline

postedOriginal Solicitation PostedMay 8, 2026
deadlineResponse DeadlineMay 13, 2026
expiryArchive DateMay 28, 2026

Agency Information

Department
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Sub-Tier
NATIONAL INSTITUTES OF HEALTH
Office
NATIONAL INSTITUTES OF HEALTH OLAO

Point of Contact

Name
Huda Malik

Place of Performance

Bethesda, Maryland, UNITED STATES

Official Sources

View on SAM.gov